Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs

NCT04465851 | Completed

• 1 other identifier: ETH1718-0907
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA production, oxygen transport and neuronal processes. However, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular oxidative stress in the body. Curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. Co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.

Conditions

Iron Deficiency (Without Anemia)

Keywords

nutraceutical; anti-oxidant; oxidative status; ferrous sulphate; curcumin; inflammatory status; turmeric; gastrointestinal; fatigue; iron; Hydrocurc; supplement

Outcome Measures

Primary Outcomes (11)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

  Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)

  Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

  Tumour Necrosis Factor alpha (pg/mL)

  Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation

  Marker: C-Reactive Protein (g/L)

  Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation

  Marker: thiobarbituric acid reactive substances (μM)

  Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption

  Marker: serum iron (μmol/L)

  Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption

  Marker: total iron binding capacity (μmol/L)

  Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

  Marker: serum iron (μmol/L)

  Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

  Marker: total iron binding capacity (μmol/L)

  Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

  Marker: Ferritin (ng/mL)

  Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

  Marker: Haemoglobin (g/dL)

  Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status

  Marker: Red blood cells (M/μL)

  Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

Secondary Outcomes (4)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels

  Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects

  Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue

  Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

• To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue

  Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)

Study Arms (5)

FS65_Curc

ACTIVE COMPARATOR

Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day

Dietary Supplement: Ferrous Sulphate 65 mg; Dietary Supplement: Curcumin

FS65_Plac

PLACEBO COMPARATOR

Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Dietary Supplement: Ferrous Sulphate 65 mg; Other: Placebo (Curcumin)

FS0_Plac

PLACEBO COMPARATOR

Placebo (Ferrous Sulphate placebo \[cellulose\]) and Placebo (Curcumin placebo \[cellulose\])

Other: Placebo (Ferrous Sulphate); Other: Placebo (Curcumin)

FS18_Plac

PLACEBO COMPARATOR

Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo \[cellulose\])

Other: Placebo (Curcumin); Dietary Supplement: Ferrous Sulphate 18mg

FS18_Curc

ACTIVE COMPARATOR

Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day

Dietary Supplement: Curcumin; Dietary Supplement: Ferrous Sulphate 18mg

Interventions

Ferrous Sulphate 65 mg DIETARY_SUPPLEMENT

Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules

Also known as: Ferrous Sulfate

FS65_Curc; FS65_Plac

Curcumin DIETARY_SUPPLEMENT

HydroCurc™ 500 mg formulated curcumin At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

Also known as: Turmeric, Curcuma longa

FS18_Curc; FS65_Curc

Placebo (Ferrous Sulphate) OTHER

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

FS0_Plac

Placebo (Curcumin) OTHER

Microcrystalline cellulose Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)

FS0_Plac; FS18_Plac; FS65_Plac

Ferrous Sulphate 18mg DIETARY_SUPPLEMENT

Oral ferrous salt supplement Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content) Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach) At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules

Also known as: Ferrous Sulfate

FS18_Curc; FS18_Plac

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Male or Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males \& Females (18-40 years of age)
• Healthy subjects

You may not qualify if:

• \<18 years or \>40 years
• Dieters
• Consumption of \>21 serving of alcohol/week
• Any allergies/health issues related to items being ingested
• Any serious illnesses or those on medication
• Any pregnant or lactating women
• Any women who are trying to conceive
• Any women taking contraceptive medication
• Any gastrointestinal disorders
• Any chronic menstrual disorders
• Any subjects who have undergone the menopause or undergoing the perimenopause transition
• Any eating disorders
• Any depression/mental disorders
• Any abnormal blood pressure levels
• Those with deficient/excess/abnormal iron levels according to United Kingdom (UK) guidelines \&/or haemochromatosis

Sponsors & Collaborators

• University of Westminster: lead
• Gencor Pacific Group: collaborator

Study Sites (1)

University of Westminster

London, W1W 6UW, United Kingdom

Location

MeSH Terms

Conditions

Iron Deficiencies; Fatigue

Interventions

ferrous sulfate; Curcumin; turmeric extract

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants (and supplements) will be coded and randomly allocated (applied randomly by software \[gender balanced\[) to treatment arms to eliminate order effects and maintain research staff blinding.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Translational Physiology

Model Details: Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 10, 2020
• Study Start: July 18, 2018
• Primary Completion: November 11, 2019
• Study Completion: January 31, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)